30 results · 24ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

OEC 9800 PLUS

FDA 510(k)
FDA Class 2 ·Radiology

NexxZr™ T / D-100-18-NT-A300-SD

FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271112378·

Baby Gorilla/Gorilla Plating System

FDA UDI
Paragon 28, Inc.·00889795145444·Ovr Dr Gd, Dbl End, 2.0/2.7mm, R3CON

Baby Gorilla/Gorilla Plating System

FDA UDI
Paragon 28, Inc.·00889795145451·Drill Guide Sleeve, 2.7mm, R3CON

CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

ASTOTUBE®

FDA Adverse Event
Malfunction ·STIHLER ELECTRONIC GMBH·Product code BSB·August 7, 2025

BIVONA SILICONE TRACHEOSTOMY TUBE

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code JOH·February 7, 2024

TRUE METRIX

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·December 23, 2025

CLEARLINK/CONTINU-FLO/DUO-VENT

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·July 22, 2025

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

ASKU

FDA Adverse Event
Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·June 16, 2011

530G INSULIN PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OZO·October 1, 2014

Affixus Hip Fracture Nail, RH 130 DEG 9MM X 420MM

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·February 7, 2018

Affixus Hip Fracture Nail, RH 130 DEG 9MM X 380MM

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·February 7, 2018

Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.

FDA Recall
Terminated ·Zimmer Dental Inc·Product code DZE·January 6, 2014

CLEARLINK/CONTINU-FLO/DUO-VENT

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·August 8, 2025

CLEARLINK/CONTINU-FLO/DUO-VENT

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·July 22, 2025

VANGUARD CEMENTED PS OPEN BOX FEMORAL -RIGHT 67.5 MM

FDA Adverse Event
Malfunction ·BIOMET ORTHOPEDICS·Product code JWH·May 4, 2017

Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.

FDA Enforcement
Class II ·Terminated·Zimmer Dental Inc·February 5, 2014